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Updated guidance from the General Medical Council (GMC) on Good practice in prescribing and managing medicines and devices came into force in April, which emphasises limits on the prescribing of controlled drugs to reduce the risk of harm.

This guidance is important to address concerns about inappropriate prescribing of controlled drugs, especially since the majority of GPs are now conducting many consultations remotely. When prescribers cannot assess the patient in person, and particularly when they do not know the patient, there may be increased risk of inappropriate prescribing.

The new GMC guidance provides clarity about prescribers’ responsibilities in this context. It applies equally to all prescribing, in any setting, including remote consultations.

Follow relevant clinical guidance on controlled drugs

Controlled drugs are subject to high levels of regulation and restrictions on how they are prescribed, supplied, stored and destroyed because they pose a risk of serious harm or are associated with dependency and misuse. Prescribers have responsibilities to ensure that they are managed and used safely.

GMC guidance states that “When prescribing, you should follow relevant clinical guidance, such as drug safety updates on the risk of dependence and addiction associated with opioids.”

Avoid prescribing controlled substances without access to patients’ records

The GMC guidance states “If you don’t have access to relevant information from the patient’s medical records you must not prescribe controlled drugs or medicines that are liable to abuse, overuse or misuse or when there is a risk of addiction and monitoring is important.”

The only exceptions are “when no other person with access to that information is available to prescribe without unsafe delay” and it is necessary:

  • “to avoid serious deterioration in health or avoid serious harm”
  • or “ensure continuity of treatment where a patient is unexpectedly without access to medication for a limited period.”

Additionally, you must not prescribe controlled drugs to yourself or someone close to you, unless the above exceptions apply, in which case clear records should be made of the reasons for action.

Understand the risks when you do not know the patient

Be mindful that there are particular risks when patients are unknown to the prescriber. Some patients may be seeking controlled drugs from multiple sources. Where it is essential to prescribe controlled drugs without access to the patients’ records, only a limited quantity and dose should be prescribed, until the records can be verified.

Reinforcing this need for caution, the Care Quality Commission (CQC) notes a worrying increase in the number of coroners’ reports where large quantities of Schedule 4 and 5 controlled drugs (not subject to the same monitoring as Schedule 2 and 3 drugs) have been prescribed and led to a patient’s death.

Contact us at Medical Defense Society for legal advice if you are concerned about an incident related to prescription of controlled drugs.

Ensure safeguards are in place for appropriate prescribing

Especially if you are prescribing remotely, GMC states “you must also be satisfied that appropriate safeguards are in place to support safe prescribing”. If you cannot be sure of this, it may be appropriate to offer an alternative mode of consultation.

Safeguards include robust identity checks, ensuring you have the patient’s consent for sharing information with their regular prescriber, and making relevant information about the prescription known to their GP or adding it to the primary care record. Notably, the guidance says that it may be unsafe to prescribe if the patient refuses consent to share this information.

As always, dialogue and clear communication are essential for safe prescribing. CQC’s review of the safer management of controlled drugs also stresses that healthcare professionals should consider the individual needs and wishes of their patients and understand that a blanket approach to prescribing is inappropriate, especially in end of life care.

Whenever prescribing controlled drugs, make sure to plan for appropriate monitoring, follow-up and review. Give the patient the names and contact details of people who will be involved in their care and who they can contact if they have questions or concerns.

Further information and guidance

BNF guidance on controlled drugs and drug dependence includes:

  • The five Schedules of controlled drugs and regulatory requirements that apply.
  • Prescription requirements for controlled drugs (all preparations in Schedules 2 and 3).
  • Responsibilities of the prescriber to avoid causing drug dependence and misuse.
  • Precautions to prevent stealing and misuse of prescription forms.

At Medical Defense Society, we are available 24/7 to provide members with advice about legal matters related to prescribing of controlled drugs.